MELCAM Tablet Ref.[28248] Active ingredients: Meloxicam

Posology

The total daily amount should be taken as a single dose.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

• Exacerbations of osteoarthrosis: 7.5 mg/day. If necessary, in the absence of improvement, the dose may be increased to 15 mg/day.
• Rheumatoid arthritis, ankylosing spondylitis: 15 mg/day (see also section “Special populations” below).

According to the therapeutic response, the dose may be reduced to 7.5 mg/day.

DO NOT EXCEED THE DOSE OF 15 MG/DAY.

Special populations

Elderly patients (see section 5.2)

The recommended dose for long term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg per day (see also section “Patients with increased risks for adverse reactions” below and section 4.4).

Patients with increased risks for adverse reaction (see section 4.4)

In patients with increased risks for adverse reactions, e.g. a history of gastro-intestinal disease or risk factors for cardiovascular disease, the treatment should be started at a dose of 7.5 mg per day.

Renal impairment (see section 5.2)

This medicine is contraindicated in non-dialysed severe renal failure (see section 4.3).

In patients with end-stage renal failure on haemodialysis, the dose should not exceed 7.5 mg per day. No dose reduction is required in patients with mild to moderate renal impairment (i.e. patients with a creatinine clearance of greater than 25 ml/min).

Hepatic impairment (see section 5.2)

No dose reduction is required in patients with mild to moderate hepatic impairment (For patients with severely impaired liver function, see section 4.3).

Paediatric population

Melcam is contraindicated in children and adolescents below 16 years of age (see section 4.3).

Method of administration

Oral use.

The tablets are swallowed with water or other fluid, during a meal.

Symptoms

Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following an overdose.

Treatment

Patients should be managed with symptomatic and supportive care following an NSAID overdose. Accelerated removal of meloxicam by 4g oral doses of cholestyramine given three times a day was demonstrated in a clinical trial.

30 months.

This medicinal product does not require any special storage conditions.

PVC/PVDC aluminium blisters.

Packs of 10, 20, 30, 50, 60 or 100 tablets.

Not all pack sizes may be marketed.

No special requirements.